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The PACT (Patient Activation Through Conversations) Study

NCT06444074 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 432

Last updated 2024-06-13

No results posted yet for this study

Summary

The PACT Study is a cluster randomised trial of a health coach-led patient activation program in type 2 diabetes. The goal of this clinical trial is to evaluate the effectiveness of a health coaching intervention (PACT program) led by Care Coaches (trained lay persons), in adult participants with sub-optimally controlled Diabetes Mellitus, as compared to participants undergoing routine care for diabetes (Usual Care).

The primary outcome of interest is change in Glycated Haemoglobin (HbA1c) levels over 3 months, 6 months and 12 months. Secondary outcomes include changes in blood pressure, low-density lipoprotein-cholesterol (LDL-C) levels, body mass index (BMI), self-reported diabetes self-care behaviours, self-efficacy, health-related quality of life, and diabetes-related distress, over 3, 6 and 12 months.

Participants in the Intervention arm will undergo the PACT Program, which is a 3-month long health coaching program led by a care coach. Participants review their motivators, health parameters, self-care behaviours, and set goals for improving their diabetes using a PACT report. Subsequently, they will receive fortnightly motivational and problem solving support via telephone or WhatsApp messaging over a 3-month duration, and will return to routine care after 3 months. Participants in the Usual Care arm will have routine care of their diabetes treatment.

Conditions

Interventions

BEHAVIORAL

Patient Activation through Conversations (PACT) Program

Participants in the intervention arm will undergo a 3-month long health coaching program where a care coach will review a participant's health parameters and current self-care behaviours, identify health motivators and set goals for improving their diabetes, as well as fortnightly support through text or phone call.

BEHAVIORAL

Usual Care

Routine Chronic Disease care

Sponsors & Collaborators

  • National Healthcare Group, Singapore

    collaborator OTHER_GOV

  • National Healthcare Group Polyclinics

    lead OTHER_GOV

Principal Investigators

  • Sabrina Kay Wye Wong, MBBS · National Healthcare Group Polyclinics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-22
Primary Completion
2025-03-31
Completion
2028-04-22

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06444074 on ClinicalTrials.gov